Z-2241-2011

NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number...

Name: Z-2241-2011 NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number...
Creator: Philips And Neusoft Medical Systems Co., Ltd.
Published: 2011-02-09
License: https://open.fda.gov/license/

Neusoft Medical Systems Co., Ltd. / initiated 2011-02-09 / Terminated

FDA source

Philips And Neusoft Medical Systems Co., Ltd. began a recall of NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part... on 2011-02-09. The reason FDA records is "Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2241-2011
Status: Terminated
Initiated: 2011-02-09
Posted: 2011-05-23
Terminated: 2011-08-24
Recalling firm: Neusoft Medical Systems Co., Ltd.
Product: NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image.
FDA root cause: Other
Action: Neusoft Medical Systems sent an Urgent Device Correction Notification letter dated February 9, 2011, via certified mail to their distributor NEUISYS. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to discontinue use of combined images. Instead, use MPR Batch for diagnostic reviews until the planned upgrade is provided to the product. Neusoft Medical System and Philips Medical System released the mandatory Field Change Order (FCO) by March 31, 2011. All nine affected systems will be updated with aforementioned kits in six months after the release. Consignees were instructed to contact Service Support Department by e-mail to [email protected]
Quantity in commerce: 9 units distributed in US
Distribution: Nationwide Distribution including CA, GA, LA, NC, OH, TN and TX.
Product codes and lots: Serial Numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, and N16E100023.

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)